Cemiplimab + Cetuximab for Head and Neck Cancer

Tampa, FL

Phase 2

Recruiting

Led By Christine Chung

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be ≥ 18 years of age at the time of consent

Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Patients who have a history of a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher

Patients with an active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a combination of cemiplimab and cetuximab before surgery is helpful and safe for people with head and neck cancer."

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Who is the study for?

Adults with head and neck squamous cell carcinoma (HNSCC) that can be surgically removed are eligible for this trial. They must have good performance status, meet lab criteria, provide tumor tissue for testing, agree to birth control if of childbearing potential, and commit to the study schedule. Excluded are those with severe allergies to similar drugs or red meat/tick bite history, HIV/Hepatitis B/C infections, certain heart conditions, active autoimmune diseases or pneumonitis.Check my eligibility

What is being tested?

The trial is testing the safety and benefits of combining two drugs—Cemiplimab and Cetuximab—before surgery in patients with HNSCC. It's a Phase II study where participants receive both medications as part of their pre-surgical treatment regimen.See study design

What are the potential side effects?

Potential side effects may include allergic reactions due to drug components; skin reactions at injection sites; flu-like symptoms such as fever or chills; fatigue; nausea; diarrhea; low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or have some restrictions but can still carry out light work.

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My head or neck cancer is operable and has not spread widely.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's pumping ability is below normal, or I have moderate to severe heart problems.

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I am currently being treated for an infection.

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I have or am currently positive for Hepatitis B or C.

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I have had pneumonitis that needed steroids or have it now.

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I have serious heart issues or uncontrolled high blood pressure.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major and Complete Pathologic Response Rate

Secondary study objectives

Event Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant Cetuximab and Cemiplimab TreatmentExperimental Treatment2 Interventions

Cemiplimab: 350 mg IV dose on C1D1 and C2D1 Cetuximab: 400mg/m2 loading dose on C1D1 followed by 250 mg/m2 IV weekly doses on C1D8, C1D15, and C2D1 (total 4 doses including the loading dose).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Cemiplimab

2015

Completed Phase 3

~1470